NCT00211250 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

Berk, M & Berk, L
(2004). Mood stabilizers and treatment adherence in bipolar disorder: addressing adverse events. Bowden C.L., Calabrese J.R., McElroy S.L., Gyulai L., Wassef A., Petty F., Pope H.G. Jr, Chou J.C., Keck P.E. Jr, Rhodes L.J., Swann A.C., Hirschfeld R.M., Wozniak P.J., (2000). Valproate in the treatment of acute mania: placebo-controlled study. Archives of General Psychiatry, 48, 62-68. Pope, S. J. (2002). Nonadherence with mood stabilizers: prevalence and predictors. Journal of Clinical Psychiatry, 63, 384-90. Sajatovic, M., Davies M., & Hrouda, D.R. (2004). Enhancement of treatment adherence with patients with bipolar disorder. Psychiatric Services, 55(3), 264-69. Depakote ER package insert, Abbott Laboratories, 2002.

An Exploratory Study Comparing Compliance, Tolerability, Efficacy and Adverse Events in Bipolar I and II Patients From Valproic Acid to Depakote ER

Clinical trial NCT00211250 - References